BEUDAMED
    FDA Adverse Event Death Summary report: N

    DUROM ACETABULAR COMPONENT

    MDR report key: 4134857 · Received September 25, 2014

    Report

    Report Number
    9613350-2014-03907
    Event Type
    Death
    Date Received
    September 25, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 8, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGESTS THAT THIS CASE MIGHT BE RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN (B)(4)2008. IT WAS CLAIMED THAT COBALT POISONING HAS CONTRIBUTED TO THE DEATH, YET NO LABORATORY REPORT OR ANY PT FOLLOW-UP HAVE BEEN MADE AVAILABLE AT THIS POINT OF TIME. SHOULD ADDITIONAL INFO BECOME AVAILABLE, AND/ OR THE DEVICES BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT IS AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    A PRODUCT LIABILITY CLAIM WAS RAISED. IT WAS REPORTED THAT THE PT WAS IMPLANTED A DUROM ACETABULAR COMPONENT ON THE LEFT SIDE ON (B)(6) 2008. CURRENTLY, THE PT DIED ON (B)(6) 2014 DUE TO COBALT POISONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599564 DUROM ACETABULAR COMPONENT DUROM ACETABULAR COMPONENT KWA ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death